Erlotinib in Combination With Pralatrexate in Advanced Malignancies

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT01532011
Phase
PHASE1
Status
Completed

Conditions

  • Advanced Cancers
  • Solid Tumors

Eligibility Criteria

Sex
ALL
Age
12 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Erlotinib — DRUG
    Dose escalation group starting dose: 75 mg by mouth daily for a 28 day cycle. Dose expansion group starting dose: Maximum tolerated dose (MTD) from dose escalation group.
  • Pralatrexate — DRUG
    Dose escalation group starting dose: 15 mg/m2 by vein on days 1, 8, and 15 of a 28 day cycle. Dose expansion group starting dose: Maximum tolerated dose (MTD) from dose escalation group.

Study Details

The goal of this clinical research study is to find the highest tolerable dose of the combination of erlotinib and pralatrexate that can be given to patients with advanced cancer. The safety of the drug combination will also be studied. Pralatrexate is designed to block the body's ability to make folic acid, a protein that may help cancer tissue to develop and spread. Erlotinib hydrochloride is designed to block proteins that are thought to cause cancer cells to grow. Erlotinib may help slow the growth of tumors.

Key Dates

First listed
Feb 13, 2012
Start date
Mar 31, 2012
Status verified
Jul 2016
Primary completion
Jun 30, 2016
Completion
Jun 30, 2016

Study Design

Enrollment
72 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Erlotinib + Pralatrexate
    Dose escalation group starting dose: Erlotinib 75 mg by mouth daily for a 28 day cycle. Starting dose of Pralatrexate 15 mg/m2 by vein on days 1, 8, and 15 of a 28 day cycle. Dose expansion group starting dose: Maximum tolerated dose (MTD) from dose escalation group.

Primary Outcome Measure

Maximum Tolerated Dose (MTD) of Erlotinib with Pralatrexate [ Time Frame: 8 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Texas MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Houston, TX

By research site
University of Texas MD Anderson Cancer Center· Houston, TX

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